Senior Principal Process Engineer (AME) - Neurovascular - Irvine, CA (Onsite)

Medtronic; Irvine (CA); On-site; USD 149,000 - 225,000; Full time

Job summary

An established industry player is seeking a Senior Principal Process Engineer to innovate and enhance manufacturing processes for neurovascular devices. In this pivotal role, you will collaborate with R&D and operations teams to drive new product introductions and ensure regulatory compliance. Your expertise in project management and process optimization will be essential in delivering high-quality medical devices. Join a diverse team dedicated to transforming healthcare and making a meaningful impact on patient outcomes. This is an exciting opportunity for those passionate about engineering and healthcare innovation.

Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Tuition Assistance

Paid Time Off

Employee Stock Purchase Plan

Life Insurance

Qualifications

• Minimum 10 years of relevant experience or 8 years with advanced degree.
• Experience in new product development within medical device manufacturing.

Responsibilities

• Lead process development initiatives for neurovascular catheter production.
• Design and validate manufacturing processes and equipment.

Skills

Project Management

Process Development

Manufacturing Optimization

Six Sigma

Statistical Tools

Leadership

Education

Bachelor's Degree

Advanced Degree

Tools

AutoCAD

SolidWorks

Microsoft Office

Job description

We anticipate the application window for this opening will close on - 23 May 2025.

At Medtronic, you can begin a lifelong career of exploration and innovation, helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

For over a decade, Medtronic has been at the forefront of transforming stroke care, leading the fight against both acute ischemic stroke (AIS) and hemorrhagic stroke. By equipping physicians with innovative technologies, we empower their expertise to improve patient outcomes and redefine neurovascular care. Our commitment extends beyond medical device development—we actively collaborate with the medical community to drive meaningful advancements in stroke treatment. Together, we are changing the way stroke is managed worldwide, making a lasting difference for the millions of patients affected every day.

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

Learn more about Neuro Vascular: Click Here

#Neuroscience

Careers That Change Lives

In this dynamic role as a Senior Principal Process Engineer within the AME team, you will play a critical role in advancing existing technologies and introducing innovative manufacturing processes, with a primary focus on neurovascular catheter production. Partnering closely with R&D, Operations, and Global Manufacturing teams, you will lead strategic process development initiatives from concept through implementation, ensuring robust process controls, readiness for high-volume manufacturing, and full regulatory compliance.

You will be responsible for selecting, developing, and validating manufacturing systems and processes to produce high-quality, cost-effective commercial medical devices. As the technical lead, you will lead a team of 5+ engineers, driving the development, validation, and continuous improvement of manufacturing processes to support New Product Introductions (NPIs) and ongoing production needs.

This role demands innovation, advanced project management capabilities, and the ability to navigate and solve complex, cross-functional challenges that impact manufacturing scalability, cost efficiency, and product quality.

Responsibilities may include the following and other duties may be assigned:

1. Lead early technology identification, feasibility studies, and pilot line development for New Product Introductions (NPIs).
2. Design, develop, and validate manufacturing processes, equipment, and fixtures; manage equipment qualification (IQ/OQ/PQ) and process validation efforts.
3. Collaborate closely with cross-functional teams to drive pre-market process improvements and smooth design transfer to Operations.
4. Conduct feasibility studies for new process technologies, support first principles engineering rigor, and apply Six Sigma and lean methodologies.
5. Mentor teams on best practices in process development, validation, and manufacturing excellence.
6. Address strategic process improvements, CAPAs, product stabilization, and manufacturing optimization initiatives.
7. Communicate and influence stakeholders across technical and leadership levels, including external suppliers and vendors.
8. Generate required technical documentation (protocols, reports, FMEAs, manufacturing instructions) while ensuring adherence to GMP and regulatory standards.

Location: Irvine, CA and Santa Ana, CA

Ability to travel up to: 25-50% between Irvine, CA and Santa Ana, CA

Must Have (Minimum Requirements)

To be considered for this role, please ensure the minimum requirements are evident on your resume.

• Bachelor’s degree required with a minimum of 10 years of relevant experience.
• OR advanced degree with a minimum of 8 years of relevant experience.

Nice to Have (Preferred Qualifications)

• Degree in Mechanical Engineering or related Engineering field is highly preferred.
• Demonstrated leadership, coaching, interpersonal skills, and experience successfully transferring projects to manufacturing.
• Prior experience in new product development within medical device manufacturing or other highly regulated environments.
• Proficiency in AutoCAD, SolidWorks, and Microsoft Office applications.
• Project Management certification and/or experience preferred.
• Green Belt certified; Six Sigma training or Black Belt certification preferred.
• Skilled in statistical tools such as DOE, SPC, Hypothesis Testing, Process Capability Studies, Minitab, and Design Expert.
• Hands-on experience with coil/embolization device manufacturing, polymer extrusion, reflow, thermal bonding, and adhesive bonding.
• Familiarity with DMAIC, A3 problem solving, DFSS/DFM principles, and COS (Cost of Service) conversion initiatives.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package.

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S. (excluding PR) locations (USD): $149,600.00 - $224,400.00. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental, and Vision insurance; Health Savings Account; Healthcare Flexible Spending Account; Life insurance; Long-term disability leave; Dependent daycare spending account; Tuition assistance/reimbursement; and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves, and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.